What should an investigator do if a new drug becomes available during an ongoing clinical trial?

When a new drug becomes available during an ongoing clinical trial, it is essential for the investigator to provide information about the new drug and discuss options with the subjects. This approach aligns with ethical standards and regulatory requirements guiding clinical research. It empowers participants by ensuring they are informed about potential alternative treatments that may be more effective or have a better safety profile than the drug being tested in the trial.

Providing detailed information allows subjects to make informed choices regarding their participation in the trial and their treatment options. It fosters transparency and trust in the research process, which is vital for participant engagement and ethical considerations. This dialogue can also lead to adjustments in the clinical trial protocol if necessary, ensuring that the study continues to prioritize participant welfare while contributing to scientific knowledge.

In contrast, simply allowing subjects to decide without any information would undermine the ethical standards of informed consent. Continuing the trial without considering the new drug could be perceived as neglecting the best interests of participants, and prohibiting switching to the new drug could create ethical concerns about the autonomy of the subjects involved. Thus, discussing options after providing adequate information is the most responsible and ethical action in this situation.